Course Description:

The US medical device regulations include Part 820, the Quality System Regulation, but extend far beyond them. In order to understand the regulations, you need to look at more than just the quality management system. This course provides an overview and shows how the parts of the regulations fit together.

The seminar will help you understand the four major parts of the US regulatory structure: laws regulations, guidance, and consensus standards. Risk class and the panels, established by law, characterize medical devices in the US. Device types fall under regulations and product codes that determine the available conformity assessment paths and provide requirements for specific cases.

The Quality System Regulation, in Part 820, provides the quality management system required to market medical devices in the US. Device design, production, installation, and servicing fall under Part 820. This part of the regulations include management responsibility for the system, design requirements, purchasing, manufacturing processes and controls, release for distribution, record keeping, etc.

After release, a device is subject to a variety of other requirements ranging for complaint management to medical device reports to recalls. Each of these requirements is in a separate part of the regulations.

This course provides a comprehensive view of the regulatory requirements to help you understand the whole picture and provide effective implementation for your company.

Learning Objectives:

Learn the law, regulations, and policies that FDA applies for medical device.

Understand the concepts of pre-market approval including device classification and conformity assessment paths.

Understand the quality management systems that govern the design, manufacture, installation, and servicing of medical devices for the US market.

Learn the role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection.

Meet Your Instructor

Dan O'LearyPresident at Ombu Enterprises, LLC

Dan O'Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

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Get the InvitationPre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
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Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

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Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Testimonial

What past attendees say

With the simple approach take by Dan, anyone can learn how to complete a successful MDD implementation.- Quality Specialist, Rochester Medica

Dan OLeary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.- Quality Manager, Parker Hannifin Corp

I enjoyed Dan's course very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company.- Compliance Coordinator, Diagnostica Stago, Inc.

I have attended webinars from ComplianceOnline but this "Live" one was incredible. This seminar was excellent.- Quality Engineering Manager, ConvaTec Inc.

I like the medical device directive and topic regarding standards. The design of the presentations was appropriate.- Director of Research and Development, Metrex Research,LLC

It was well organized event by ComplianceOnline. Communication was good. Presenter was very knowledgeable. Practical application of directives, standards, regulations are very helpful.- Manager, Quality Assurance, Instrumentation Laboratory

It was well organized event by ComplianceOnline with good subject matter and knowledgeable instructor.- Director of Operations and Quality, NDI Medical LLC

I appreciate the knowledge given at this seminar. Speaker is very experienced and I found good talent here. I am very happy with first class reference sheet.- Sr. CAPA Specialist, Johnson & Johnson Vision Care Inc

Knowledgeable speaker with great real life examples and discussions.- Quality Director, Lifecore Biomedical

It was a well organized seminar. It provides trainees a good understanding about the CA-PA process that complies with regulatory standards.- QA/RA Representative, ResMed Corp

It was my first conference with ComplianceOnline and experience was good. Love the reference material and flash key.- Quality Assurance, Beckman Coulter

Seminar was very informational with great resources. Topics were covered in depth.- Quality Assurance, Encoll Corp

Session was very informative. Dan did a great job covering a lot of information, comprehensively, within such a short time of just 2 days. Can't wait to attend my next ComplianceOnline seminar.- President, Medi-Stim, Inc

Seminar was very informative and helpful.- Operations Director, Medi-Stim, Inc.

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